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Last Updated: March 29, 2025

TERRAMYCIN W/ POLYMYXIN Drug Patent Profile


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Summary for TERRAMYCIN W/ POLYMYXIN
US Patents:0
Applicants:2
NDAs:2
DailyMed Link:TERRAMYCIN W/ POLYMYXIN at DailyMed
Drug patent expirations by year for TERRAMYCIN W/ POLYMYXIN

US Patents and Regulatory Information for TERRAMYCIN W/ POLYMYXIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Casper Pharma Llc TERRAMYCIN W/ POLYMYXIN B SULFATE oxytetracycline hydrochloride; polymyxin b sulfate OINTMENT;OPHTHALMIC 061015-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pfizer TERRAMYCIN W/ POLYMYXIN oxytetracycline hydrochloride; polymyxin b sulfate OINTMENT;OTIC 061841-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Market Dynamics and Financial Trajectory for Terramycin with Polymyxin B

Introduction

Terramycin with Polymyxin B is a widely used ophthalmic ointment indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea. This article delves into the market dynamics and financial trajectory of this drug, highlighting its indications, market presence, and financial aspects.

Indications and Usage

Terramycin with Polymyxin B is specifically designed to treat superficial ocular infections caused by susceptible microorganisms. It is effective against a broad spectrum of bacteria, including gram-positive and gram-negative organisms, such as staphylococci, streptococci, pneumococci, Hemophilus influenzae, Pseudomonas aeruginosa, and Koch-Weeks bacillus[1][2][3].

Market Presence

Historical Availability

Terramycin with Polymyxin B has experienced fluctuations in its market availability. After a hiatus from June 2012 to October 2014, when Pfizer Animal Health stopped production, the drug was reintroduced to the US market by Zoetis. This reintroduction was significant, especially for veterinary use, as it provided a commercially manufactured alternative to compounded versions[5].

Current Market

The drug is currently supplied by major pharmaceutical companies such as Pfizer and Zoetis. It is available in various regions, including the US, and is widely used in both human and veterinary medicine. The broad-spectrum effectiveness and synergistic action of oxytetracycline and polymyxin B make it a preferred choice for treating ocular infections[1][2][5].

Financial Trajectory

Revenue and Sales

The financial performance of Terramycin with Polymyxin B can be gauged from its consistent demand and market presence. Although specific revenue figures are not publicly disclosed for this particular drug, its reintroduction and continued use indicate a stable revenue stream. The drug's broad-spectrum effectiveness and the lack of suitable alternatives contribute to its financial stability.

Cost and Pricing

The cost of Terramycin with Polymyxin B can vary depending on the region and the supplier. However, it is generally priced competitively within the ophthalmic antibiotic market. The drug is supplied in 1/8 oz (3.5 g) tubes, which helps in managing costs for both patients and healthcare providers[1][2].

Competitive Landscape

Market Competitors

The ophthalmic antibiotic market is competitive, with several other drugs available for treating ocular infections. However, Terramycin with Polymyxin B stands out due to its broad-spectrum activity and synergistic effects. Competitors include other antibiotic ointments and drops, but the unique combination of oxytetracycline and polymyxin B gives Terramycin a distinct market position[1][2][3].

Differentiation

The synergistic action of oxytetracycline and polymyxin B is a key differentiator for Terramycin. This combination is particularly effective against gram-negative organisms, such as Pseudomonas aeruginosa, which are often resistant to other antibiotics. This differentiation helps in maintaining a strong market presence despite competition[1][2][3].

Regulatory Environment

Approval and Compliance

Terramycin with Polymyxin B is approved for use in various countries, including the US. It must comply with regulatory standards set by agencies such as the FDA. The drug's labeling and packaging must adhere to strict guidelines to ensure safety and efficacy[1][2][3].

Safety and Efficacy

The drug is well-tolerated by the epithelial membranes and other tissues of the eye, with rare allergic or inflammatory reactions. However, it is contraindicated in patients with hypersensitivity to any of its components. Regulatory bodies closely monitor its safety and efficacy to ensure it meets the required standards[1][2][3].

Patient and Veterinary Use

Human Use

In humans, Terramycin with Polymyxin B is used to treat a variety of superficial ocular infections. It is administered topically, and patients are advised to avoid contaminating the tube tip to prevent infection spread. The drug can be used alone or as an adjunct to systemic therapy in severe cases[1][2][3].

Veterinary Use

In veterinary medicine, Terramycin with Polymyxin B is indicated for dogs and cats with superficial ocular infections such as conjunctivitis, keratitis, and corneal ulcers. It is particularly useful in treating secondary bacterial complications of distemper in dogs. The broad-spectrum effectiveness makes it a valuable tool in veterinary ophthalmology[5].

Future Outlook

Market Trends

The demand for effective ophthalmic antibiotics is expected to continue, driven by the increasing incidence of ocular infections and the need for broad-spectrum treatments. Terramycin with Polymyxin B is well-positioned to meet this demand due to its proven efficacy and safety profile.

Research and Development

While Terramycin with Polymyxin B remains a staple in ophthalmic care, ongoing research into antibiotic combinations, such as polymyxin B and minocycline, highlights the potential for future advancements in treating resistant bacterial infections. These developments could influence the market dynamics and financial trajectory of Terramycin and similar drugs[4].

Key Takeaways

  • Broad-Spectrum Efficacy: Terramycin with Polymyxin B is effective against a wide range of gram-positive and gram-negative bacteria.
  • Synergistic Action: The combination of oxytetracycline and polymyxin B provides a synergistic effect, enhancing its antimicrobial activity.
  • Market Stability: The drug has a stable market presence, supported by its consistent demand and competitive pricing.
  • Regulatory Compliance: It must adhere to strict regulatory standards to ensure safety and efficacy.
  • Future Outlook: The drug is well-positioned to meet ongoing demand for effective ophthalmic antibiotics.

FAQs

Q: What is Terramycin with Polymyxin B used for? A: Terramycin with Polymyxin B is used to treat superficial ocular infections involving the conjunctiva and/or cornea caused by susceptible microorganisms.

Q: How is Terramycin with Polymyxin B administered? A: It is administered topically as an ointment, applied into the conjunctival sac of the lower lid 4 to 6 times daily.

Q: What are the key components of Terramycin with Polymyxin B? A: The key components are oxytetracycline hydrochloride and polymyxin B sulfate.

Q: Is Terramycin with Polymyxin B safe for use in children? A: While it is generally safe, systemic administration of tetracyclines during tooth development can cause permanent discoloration of teeth and other skeletal effects. Topical use is less likely to cause these effects but should still be considered[3].

Q: Can Terramycin with Polymyxin B be used in veterinary medicine? A: Yes, it is indicated for dogs and cats with superficial ocular infections such as conjunctivitis, keratitis, and corneal ulcers[5].

Sources

  1. Drugs.com: Terramycin with Polymyxin B: Package Insert / Prescribing Info.
  2. Pfizer: Terramycin Ophthalmic Ointment.
  3. Pfizer: Terramycin® Oxytetracycline HCl Polymyxin B Sulfate.
  4. Oxford Academic: Synergy of polymyxin B and minocycline against KPC-3- and OXA-48-producing Klebsiella pneumoniae.
  5. MSPCA-Angell: Terramycin Returns To The US.

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